The present invention relates generally to a composition for the treatment or prophylaxis of allergic and inflammatory reactions such as but not limited to Type I hypersensitivity reactions in mammals. More particularly, the present invention is directed to compositions comprising herbs or extracts of herbs or botanical or horticultural equivalents of the herbs or chemical or functional equivalents of the herbal extracts useful in the treatment or prophylaxis of allergic and inflammatory reactions such as but not limited to respiratory disorders. The present invention further contemplates a method of treating allergic and inflammatory reactions in mammals and in particular Type I hypersensitivity disorders and even more particularly respiratory disorders by the administration of a herbal composition or its chemical or functional equivalent.
Allergic and inflammatory reactions in mammals are responsible for conditions which range from minor discomfort to death. The latter is particularly the case following, for example, a compromised respiratory system resulting from an allergic reaction in the nasal or bronchial passages.
An example of a less severe allergic reaction in the respiratory system is allergic rhinitis. Allergic rhinitis generally occurs when a sensitized individual is re-exposed to a foreign substance or allergen. The first exposure by the individual generates allergen-specific antibodies and, in particular, IgE antibodies. This process is generally facilitated by the production of IL-4 by helper T cells. The IgE antibodies bind to mast cells via the Fcxcex5 R1 receptor. Once sufficient IgE antibodies are present on the surface of mast cells, exposure to the same allergen induces mast-cell activation and acute allergic reaction. The specific result is allergic rhinitis or hayfever. The most common form of hayfever results from exposure to pollen. The allergic reaction is not so much from pollen per se but from allergenic proteins present in the pollen. Mast cells carrying surface allergen-specific IgE molecules release inflammatory mediators once the IgE antibodies are cross-linked by the allergens. The inflammatory mediators are contained in secretary granules. Antigen cross-linking of bound IgE antibodies triggers rapid local inflammation and eventually the symptoms of hayfever and asthma.
One of the inflammatory mediators is histamine. Although there is no known cure for allergic rhinitis, symptomatic-based therapies have been developed which include the administration of anti-histamines to reduce the inflammatory effects of histamines.
Herbal formulations comprising extracts of more than one herbal plant have been used for centuries in Traditional Chinese Medicine (TCM). There is now an increasing acceptance of their value and therapeutic efficacy in Western medicine. TCM has its own unique and philosophical theory in etiology pathology, diagnosis, pharmacology and therapeutics. Many concepts surrounding TCM have particular relevance to Western medicine such as viewing parts of the body as an organic whole, considering inter-relations and influences between organs and being aware of relevant adaptation of the human body to the natural environment.
There are two major principles in the utilization of herbs in the management of diseases: individualized treatment and the use of herbal formulations.
Herbal formulations have been previously described in the literature in the treatment of respiratory disorders. For example, Shen Ziyin and colleagues, Journal of Traditional Chinese Medicine 2: 135-140, 1998 describe the use of a mixture of herbs including Radix Aconiti, Radix Rehmanniae Praeparata, Rhizoma, Dioscoreae, Fructus Corni, Herba Eistanchis, Herba Epimedii, Fructus Psoraleae, Semen Cuscutae and Pericarpium Citri Reticulatae. These herbs were selected to restore Kidney-yang in a treatment known as Kidney Reinforcement Regimen (KRR). It was proposed that the KRR induced by the administration of the above mixture of herbs strengthened the function of the hypotbalamus-pituitary-adrenocortical axis and this modulated immunological function in the treatment of seasonal asthma.
Another herbal formulation is referred to as the xe2x80x9cWen Yang Pillxe2x80x9d and was described by Shen Ziyin and colleagues at the 4th International Congress of Oriental Medicine, Kyoto, Japan in 1985. The Wen Yang Pill comprises the herbs Radix Aconiti, Radix Rehmanniae, Radix Dioscoreae oppositae, Herba Epimedii, Semen Psoraeleae and Semen cuscuatae. 
However, despite a large range of herbal formulations being described, very few have been the subject of properly controlled studies especially in relation to the treatment of respiratory disorders.
In work leading up to the present invention, the inventor identified a herbal formulation which was shown in randomized, double-blind, placebo-controlled, parallel-grouped clinical trials to be effective in the treatment of allergic and inflammatory reactions in mammals. The herbal formulation of the present invention is particularly useful in the treatment or prophylaxis of Type I hypersensitivity reactions such as but not limited to IgE-based respiratory disorders.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word xe2x80x9ccomprisexe2x80x9d, and variations such as xe2x80x9ccomprisesxe2x80x9d and xe2x80x9ccomprisingxe2x80x9d, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
One aspect of the present invention provides a composition comprising herbs or an extract of herbs or botanical or horticultural equivalents of herbs or chemical or functional equivalents of the herbal extract wherein said composition is effective in the prophylaxis or treatment of an allergic or inflammatory response.
Another aspect of the present invention is directed to a composition comprising herbs or an extract of herbs or botanical or horticultural equivalents of herbs or chemical or functional equivalents of the herbal extract wherein said composition is effective in the prophylaxis or treatment of an allergic or inflammatory response as determined by a placebo-controlled trial.
A further aspect of the present invention comprises a composition comprising herbs or an extract of herbs or botanical or horticultural equivalents of herbs of chemical or functional equivalents of the herbal extract wherein said composition is effective in the prophylaxis or treatment of an allergic or inflammatory response and wherein said herbs in the composition are selected to:
(i) keep airways open;
(ii) invigorate the spleen and digestive system;
(iii) reinforce the kidney and function of the urinary and reproductive tract;
(iv) eliminate inflammation; and
(v) promote blood circulation and remove blood stasis.
Yet another aspect of the present invention is directed to a composition comprising herbs or an extract of herbs of botanical or horticultural equivalents of herbs or chemical of functional equivalents of the herb extract wherein said composition is effective in the prophylaxis or treatment of an allergic or inflammatory response and wherein said herbs in the composition are selected from first, second, third, fourth and fifth groups of herbs wherein the first groups comprises: Mahuang, Guizhi, Cangerzi, Xinyi, Bohe, Xixin, xingren, Chaihu, Yinxingye, Baizi and Fangfeng; the second group comprises: Baizhu, Shanyao, Dangshen, Dazao, Gancao, Huangqi and Huangjing; the third group comprises: Tusizi, Roucongrong, Fuzi, Yinyanghuo, Buguzhi, Dihuang and Xianmao; the fourth group comprises: Huangqin, Wumei and Wuweizi; the fifth group comprises: Taoren, Chuanxiong, Danpi and Chishao.
Still another aspect of the present invention contemplates a composition comprising five or more herbs or extracts thereof or botanical or horticultural equivalents of the herbs or chemical or functional equivalents of the herbal extracts, said herbs selected from the list comprising at least one from five groups of herbs wherein the first group comprises: Mahuang, Guizhi, Cangerzi, Xinyi, Bohe, Xixin, Xingren, Chaihu, Yinxingye, Baizi and Fangfeng; the second group comprises: Baizhu, Shanyao, Dangshen, Dazao, Gancao, Huangqi and Huangjing; the third group comprises: Tusizi, Roucongrong, Fuzi, Yinyanghuo, Buguzhi, Dihuang and Xianmao; the fourth group comprises: Huangqin, Wumei and Wuweizi; the fifth group comprises: Taoren, Chuanxiong, Danpi and Chishao.
Even still another aspect of the present invention provides a composition comprises five or more herbs or extracts of five or more herbs selected from the list comprising:
the rhizome of Rehmannia Glutinosa Libosch, Dihuang; the root of Scutellaria Baicalenis Georgi, Huangqin; the rhizome of Polygonatum Sibiricum Redout, Huangjing; the leaf of Ginkgo Bilobo, Yinxingye; the leaf of Epimedium Sagittatum, Yinyanghuo; the ripe fruit of Psoralea Corylifolia, Buguzhi; the fruit of Schisandra Chinensis Baill, Wuweizi; the unripe fruit of Prunus Mume Sieb without seed, Wumei; the root of Ledebouriella Divaricata Hiroe, Fangfeng; the root of Angelcae Dahuricae, Baizi; the root of Astragalus Membranaceus, Huanqi, wherein the composition comprises at least one kidney-tonifying herb or an extract thereof and at least one herb or an extract thereof for respiratory disorders.
Another aspect of the present invention contemplates a method for the treatment or prophylaxis of an allergic or inflammatory reaction such as but not limited to a Type I hypersensitivity reaction (e.g. IgE-based allergic reaction) and in particular a respiratory disorder in a mammal, said method comprising administering an effective amount of the composition as hereinbefore described for a time and under conditions sufficient to treat or prevent said allergic or inflammatory reaction.